1. Field Of The Invention
Multiple sclerosis (MS) is a chronic, often disabling disease of the central nervous system. Clinically, MS is highly variable and there is no specific diagnostic test. In a large proportion of the patients, the disease is manifested by unpredictable attacks called exacerbations followed by quiescent periods called remissions. The duration of these remissions is uncertain and exacerbations are not predictable.
At present, the cause of MS is not known and there is no known cure. However, there is evidence which is consistent with an agent, such as a virus, which leads to a defective "autoimmune" response. Treatment of the disease involves the use of steroids and other drugs which can have serious side effects and whose administration for prolonged periods is undesirable. To the extent that these drugs could anticipate an exacerbation, to inhibit or diminish the disorienting effects of the exacerbation, it would be desirable to be able to predict the onset of an exacerbation. In addition, the ability to predict a remission would also be useful, so that treatment during the exacerbation could be rapidly terminated at the earliest time. Furthermore, a means of diagnosing or confirming the diagnosis of MS would be extremely useful.
2. Brief Description Of The Prior Art
Lisak et al., Clin. Exp. Immunol (1975) 22:30-34 suggested that autoimmunity plays a role in multiple sclerosis. The presence of abnormalities in T-cell subsets as determined with a monoclonal antibody to the TP 32 cell surface antigen was reported by Werner and Hauser, Ann. Neurol. (1982) 11:437 and Oger et al., Neuro. Clinica. (1983) 1:655, as well as Reinherz and Schlossman, N. Eng. J. Med. (1980) 303:125, who reported that there were T suppressor cell deficiencies. See also Hauser et al., Ann. Neurol. (1983) 13:418-425. Results, contrary to the results reported in the above citations, have been published in studies by Kastrukoff and Paty, Ann. Neurol. (1984) 15:250-256 and Paty et al., Ibid. (1983) 14:455.
The use of multiple parameter flow cytometric analysis for the study of normal human peripheral blood lymphocytes is exemplified in Hardy et al., Ann. N.Y. Acad. Sci. (1982) 399:112, Lanier and Loken, J. of Immunol. (1984) 132:151, Lanier et al., Ibid. (1983) 131:1789 and Lanier et al., Immunological Rev. (1983) 74:143.